The Center for Learning and Health
Baltimore, Maryland, 21224, United States
NCT Number: NCT00684775
The purpose of this study is to determine whether employment-based naltrexone treatment proves effective in promoting depot naltrexone adherence and drug abstinence.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
Baltimore, Maryland, 21224, United States
A randomized study is planned to evaluate the effectiveness of employment-based reinforcement in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an extended-release depot formulation of naltrexone approved by the FDA for the treatment of alcohol dependence, will be used. Participants will be offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working and earning salary by taking depot naltrexone injections once per month. "Work Plus Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly, but access to working and earning salary will not be contingent on doing so.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Individuals were eligible if they:
Individuals were excluded if they:
Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
Other names: contingency management
Time frame: 24 weeks
The percentage of depot naltrexone doses that participants received
Time frame: 24 weeks
The time to the first missed dose of depot naltrexone
Time frame: Collected every 30 days for 150 days
Percentage of urine samples collected at the 30-day assessments that are negative for opiates
Time frame: Collected every Monday, Wednesday and Friday for 24 weeks
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for cocaine
Time frame: Collected every 30 days for 150 days
The percentage of urine samples collected at 30-day assessments that are negative for cocaine.
Time frame: 24 weeks
behaviors that place participants at risk for acquiring or transmitting HIV infection
Time frame: Collected every Monday, Wednesday and Friday for 24 weeks
Percentage of urine samples collected Monday, Wednesday and Friday at the workplace that are negative for opiates
Johns Hopkins University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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